Regulatory Affairs Specialist 3

We have an excellent opportunity with our client for the position of Regulatory Affairs Specialist 3 at Tarrytown, NY. Please review the information below and if you are available; please reply back with a copy of your resume and best number to reach you.
 
Location: Tarrytown, NY 10591
Duration: 7-8 Months
 
Description
The RA Technical Specialist Level 3 is a member of the TTN international RA team and is responsible for supporting international product registrations for ADVIA products. 
 
Brief description of the primary accountabilities: 
o Creates and implements strategies to support Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America and Europe in registering ADVIA products 
o Liaises with RA core team and design change team members to support product registrations worldwide. 
o Various interdepartmental communications with marketing, manufacturing, R&D, OEMs, labeling, and others to support an efficient and effective international product registration process. 
The position reports to the Sr. Manager, Regulatory Affairs. 
 
Responsibilities: 
o Interacts with other international RA colleagues to establish best practices. 
o Effective interdepartmental communications. 
o Organizes and supports international regulatory submission dossiers for ADVIA product line. 
o Provides answers to technical questions from international regulatory authorities. 
o Review and provide technical documents (test reports). 
o Leads projects related to new product registrations, license renewals, and re-registration requests using RAPID database.
 
Required Knowledge/Skills, Education, and Experience 
o Advanced degree 
o 4+ years regulatory affairs experience. 
o Knowledge and experience with global registrations of IVDs. 
o None or very minimal (?5%) 
o Good technical writing skills 
o Ability to read and interpret technical reports 
o Knowledge of regulatory requirements worldwide 
o Creative and adept at problem solving 
o Effective communication skills 
o Great focus with attention to detail 
o Able to multi-task and work effectively in a dynamic environment 
o Skilled in Outlook, Adobe Acrobat and Microsoft Office applications 
o Able to work independently 
 
Preferred Knowledge/Skills, Education, and Experience 
o College degree in a scientific discipline. 
o Experience communicating with non-native English speakers 
o Experience in laboratory environment (e.g., Med Tech background) 
o Bi-lingual, preferably mandarin 
o Intercultural sensitivity
 
Regards
 
Daya Poojary
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560
daya@apninc.com
Phone: 510-857-5736
Fax: 510-623-5055 

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